Kornimate/medical-research-clean huggingface dataset:
study comparing best medical practice with or without vns therapy in pharmacoresistant partial epilepsy patients

Conditions: Epilepsy; Partial Epilepsy

Summary: this is a post-market medical device study. this study will compare best medical practice with or without adjunctive vns therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

this is a post-market medical device study. this study will compare best medical practice with or without adjunctive vns therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. the sponsor, cyberonics, provides funding for this study. patients are followed for 26 months, 24 of those months are following the initiation of treatment. no study sites will be permitted to enroll study subjects until institutional review board (irb)/ethics committee (ec) approval has been received.

Eligibility criteria:
inclusion criteria: * patient has confirmed partial onset seizures. * seizure activity is not adequately controlled by patient's current aed regimen. * patient is between 16 and 75 years of age. * patient is able to give accurate seizure counts and health outcomes information. patient is able to complete study instruments with minimal assistance. * patient has previously failed at least 3 aeds in single or combination use. * during baseline evaluation period, patient should take at least 1 aed. * patient should have confirmed epilepsy for a minimum of 2 years. * patient's aed regimen is stable for at least 1 month prior to enrolment. * patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment. * patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. exclusion criteria: * patient has pseudoseizures or a history of pseudoseizures. * patient has idiopathic generalised epilepsy or unclassified epilepsy. * patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy. * patient has had a unilateral or bilateral cervical vagotomy. * patient has a history of non-compliance with the completion of a seizure diary. * patient has taken an investigational drug within a period of 3 months prior to inclusion. * patient is currently using another investigational medical device. * patient has a significant cardiac or pulmonary condition currently under treatment. * patient has previously undergone brain surgery. * patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator. * patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the study.

Keywords: epilepsy vns therapy
a prospective multicenters clinical cohort study of stratified treatment of chinese children with lbl

Conditions: Lymphoma, Non-Hodgkin; Lymphoblastic Lymphoma, Childhood; PTEN Loss; NOTCH1 Gene Mutation; Pediatric Cancer

Summary: with the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-hodgkin lymphoma (nhl) in children. in recent years, the criteria for clinical staging and efficacy evaluation of nhl in children have been updated. recent clinical studies of cog in the united states and lmb in france have confirmed that molecular biological markers such as notch1, pten and loh6q are significantly associated with the prognosis of t-lymphoblastic lymphoma (t-lbl). these molecular biological markers should be included in the new risk stratification system. high-intensity treatment of high-risk patients will improve survival. recent studies have also suggested that pet/ct is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. in order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of nhl in children. scccg-lbl-2017 was formulated by south china children's cancer group of non-hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..

research purpose: 1. to investigate the efficacy and safety of scccg-lbl-2017 in chinese children with lbl. 2. to explore the feasibility of risk stratification of t-lbl by combining genotyping. 3. to investigate the correlation between mdd and mrd in lymphoblastic lymphoma and prognosis. 4. to investigate the role of pet/ct in the assessment of residual lymphoblastic lymphoma. 5. to explore the effect of reducing hd-mtx dosage and shortening maintenance therapy time on the efficacy and survival of low-risk lbl patients. 6. to explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk lbl patients.

Eligibility criteria:
inclusion criteria: 1. age \< 18 years old 2. pathologically confirmed lymphoblastic lymphoma 3. newly diagnosed patients 4. informed consent of guardian of children patients - exclusion criteria: 1. age \> 18 years old 2. recurrent lymphoblastic lymphoma 3. secondary immunodeficiency.
fluid-dynamics in bifurcation pci

Conditions: Atherosclerosis, Coronary

Summary: investigator-initiated, international, multicentre, observational study with two cohorts. the two study cohorts will be: cohort a: to understand if the local blood flow patterns (associated with low wss), as evaluated by computational fluid dynamic tools from combined angiographic and oct invasive images, may better predict the clinical outcome of patients with bifurcated coronary lesions treated by pci. cohort b: to understand if the local blood flow patterns (associated with low wss), as evaluated by computational fluid dynamic tools from combined angiographic and oct invasive images, may better predict the clinical outcome of patients with sub-critical bifurcated lesions managed conservatively. coronary angiography and oct images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the time-averaged wss at the bifurcated lesion level by using computational fluid dynamics software. baseline (in patients both managed conservatively and treated by pci) and post-pci (in patients treated by pci) images will be processed.


Eligibility criteria:
inclusion criteria * patients with stable or unstable coronary artery disease; * timi 3 on both mv and sb; * mv visual diameter \> 2.5 mm; * sb visual diameter \> 2.0 mm; * documentation of angiographically-critical (visually estimated percentage diameter stenosis ≥80% \<100%) coronary lesion treated by pci and underwent post-pci oct assessment or angiographically-intermediate (visually estimated percentage diameter stenosis ranging between 30-80%) lesion in the mv considered suitable for conservative management (myocardial revascularization not planned). exclusion criteria * age \< 18 years or impossibility to give informed consent. * female sex with child-bearing potential. * life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc.). * ascertained or suspected contraindications to prolonged (up to 6 month) double antiplatelet therapy. * known hypersensitivity to aspirin, heparin, contrast dye, sirolimus, everolimus, zotarolimus, cobalt, chromium, nickel, tungsten acrylic, and fluoro-polymers. * poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%. * recent (\< 48 hours) st-segment elevation myocardial infarction. * severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ecg sokolow's criteria fulfilled). * severe valvular heart disease. * significant platelet count alteration (\ 700,000 cells/mm3). * gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks. * history of clotting pathology. * advance renal failure with glomerular filtration rate \< 30 ml/min (cockcroft-gault equation) * left main lesion. * target bifurcation located on a distal coronary segment.

Keywords: optical coherence tomography percutaneous coronary interventions coronary atherosclerosis in bifurcations
s-icd® system post approval study

Conditions: Primary Prevention of Sudden Cardiac Arrest; Secondary Prevention of Sudden Cardiac Arrest

Summary: the purpose of the s-icd post approval study is to document long term safety and effectiveness outcomes associated with the implantation of the sq-rx pulse generator and q-trak electrode in a commercial clinical setting.

the s-icd post approval study is a non-randomized registry that will retrospectively enroll subjects who participated in the s-icd clinical investigation (ide g090013) and prospectively enroll new candidates for the s-icd system. the target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months. * the primary safety endpoint of the study is the type i (caused by the s-icd system) complication free rate at 60 months compared to a performance goal of 85%. * the primary effectiveness endpoint is the overall shock effectiveness in converting spontaneous discrete episodes of ventricular tachycardia /ventricular fibrillation (vt/vf) through 60 months compared to a performance goal of 94%. * the secondary safety endpoint of the study is the electrode-related complication free rate at 60 months compared to a performance goal of 92.5%. * the secondary effectiveness endpoint is first shock effectiveness in converting induced (acute) and spontaneous discrete episodes of vt/vf through 60 months compared to a performance goal of 84.0%. additional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations. subjects must meet the following criteria to be eligible for inclusion in the study: 1. eligible for implantation with an s-icd system, or previously implanted with an s-icd system in the s-icd system clinical investigation (ide g090013) 2. willing and able to provide written informed consent or have informed consent provided by a legal representative subjects who meet the following criteria must be excluded from the study: 1. remaining life expectancy of less than 360 days enrolled subjects will be followed at the implant procedure, pre-discharge and annual (±60 days) follow-up visits. subjects are followed according to the standard of care at their participating investigational center. the primary and secondary safety and effectiveness endpoints will include a compilation of s-icd ide study and s-icd pas study subject data

Eligibility criteria:
inclusion criteria: * eligible for implantation with an s-icd system, or previously implanted with an s-icd system in the s-icd system clinical investigation (ide g090013) and * willing and able to provide written informed consent or have informed consent provided by a legal representative exclusion criteria: * remaining life expectancy of less than 360 days

Keywords: subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, cameron health defibrillator
multi-parametric mri assessment of the liver in the dallas-fortworth metroplex population

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: to build a registry of volunteers by inviting them to get a livermultiscan(lms)and collecting their contact information to seek interest in participating in future studies.

this is a registry where there will be no intervention to the standard of care.participants will be required to attend a single visit that will involve having a multi-parametric mri at no cost to them. in addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. additionally, the contact information of the participants medical providers shall be collected so that, if requested, their lms reports can be used in their diagnostic pathway. imaging will be performed at two touchstone imaging locations, one in downtown dallas and the other in southlake. a total of 100 participants will be enrolled over a period of 1 year.

Eligibility criteria:
inclusion criteria: * male or female volunteers aged 18 years and over• * participant willing and able to give informed consent for participation in the registry. exclusion criteria: * the participant may not enter the registry if they have any contraindication to magnetic resonance imaging (standard mr exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
composite cartilage perichondrium graft for air bone gap closure in chronic suppurative otitis media (csom) without posterior meatal flap

Conditions: Tympanic Membrane Perforation

Summary: composite cartilage perichondrium graft for tympanoplasty in chronic suppurative otitis media (csom) air bone gap (ab gap) closure will be taken as successful outcome endoscopic technique without posterior meatal flap elevation

300 eligible cases of dry csom will under go composite cartilage perichondrium graft tympanoplasty. air bone gap closure will be taken as successful outcome. the procedure will employ endoscopic technique without posterior meatal flap elevation.

Eligibility criteria:
inclusion criteria: 1. both genders between 21 to 55 years 2. dry chronic suppurative otitis media 3. air bone gap between 15 to 25 deci bel exclusion criteria: 1. discharging ear 2. pediatric population 3. ossicular necrosis 4. previous ear surgery
genetic newborn screening for rare diseases within the screen4care project

Conditions: Newborn Screening

Summary: the main objective of the genetic newborn screening part of the screen4care-project is to shorten the path to rare disease diagnosis and to facilitate early intervention. therefore, genetic newborn screening for currently treatable rare diseases (treat-panel approach) will be offered to families expecting a baby. whole genome sequencing (wgs) will be offered as additional diagnostic approach to newborns participating in screen4care treat-panel approach, if they develop symptoms suggestive of a genetic disease. to evaluate to what extend genetic newborn screening has an impact on participating infants and their families, a follow-up with standardised questionnaires will be performed for all participating families.


Eligibility criteria:
inclusion criteria: * treat-panel: * newborns * infants born in one of the participating hospitals and birth centres * informed consent signed by both parents/legal guardian to participate in genetic newborn screening (treat-panel) * whole genome sequencing: * participation in the treat-panel study * symptoms suggestive of a genetic disease within the first 2 years of life * informed consent signed by both parents/legal guardian to participate in genetic newborn screening (treat-panel) and the whole genome sequencing exclusion criteria: * missing informed consent of parents/legal guardian
enhanced screening for early treatment targets after mtbi

Conditions: Brain Concussion

Summary: the study will examine whether enhancing screening-informed follow-up letters will improve (i) family physician compliance with best practice guidelines for managing persistent symptoms following concussion, and (ii) clinical outcomes from concussion.

family physicians are well positioned to proactively manage symptoms in the weeks following mtbi, which could prevent chronicity and reduce the need for specialist treatment. clinical practice guidelines are now available for mtbi management in primary care, such as those developed by the ontario neurotrauma foundation (onf). however, awareness and use of these guidelines may be low. distilling the guidelines into a small number of actionable messages that are tailored to an individual patient may facilitate family physician implementation. the onf guidelines for mtbi propose that early intervention should prioritize the most readily treatable symptoms - mood (depression and anxiety), insomnia, and headaches. the present cluster randomized trial will evaluate whether screening for these conditions and sending family physicians treatment algorithms for positive screening test results will result in earlier evidence-based treatment. patients will be recruited from two concussion clinics that provide group education sessions. following the education session, eligible participants will complete self-reported screening measures for depression, anxiety, insomnia, and headaches. family physicians will be randomized to receive these screening test results with associated treatment algorithms from the onf guidelines or a letter providing generic mtbi management recommendations from the onf guidelines (currently done as usual care). patients will be assessed by telephone one month and three months after the intervention. the primary outcome will be patient-reported treatment utilization that is congruent with the onf guidelines for depression, anxiety, insomnia, and headaches after mtbi.

Eligibility criteria:
inclusion criteria: * aged 18 to 60 years. * has a family physician. * physician diagnosed mtbi less than 3 months ago. * english reading comprehension sufficient for the consent form and standardized questionnaires. exclusion criteria: * english reading comprehension not sufficient for the consent form and standardized questionnaires.
prevention of sacral pressure ulcers with preventive dressings

Conditions: Grade I to Grade IV Pressure Ulcers in Higher Risk Patients

Summary: in this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a mepilex sacral dressing. the research question we would like to answer is the following: is the mepilex sacral dressing a cost-effective dressing for the prevention of grade i to grade iv pressure ulcers in the sacral region in higher-risk hospitalized patients?


Eligibility criteria:
inclusion criteria: * age: ≥18 years * admission in one of the ten high-risk departments of the azm * suspected hospital stay of 5 days or more after admission * braden score 19 or less exclusion criteria: * age: \<18 years * pre-existing sacral pressure ulcer * pre-existing trauma to the sacrum * patient is unable to speak dutch * patients with an inability to give informed consent * patients who are unable to give informed consent within 24h after admission * patients who are unable to give informed consent before surgery

Keywords: pressure ulcer dressing prevention higher risk patients
protein hydrolyzation and glycemic control

Conditions: Diabetes

Summary: the insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. the objective of the study is to investigate the optimal dose of such an insulinotropic mixture.


Eligibility criteria:
inclusion criteria: * male * age between 40 and 70 years * oral blood glucose lowering medication * bmi \< 35 kg/m2 exclusion criteria: * exogenous insulin use * cardiac disease (any cardiac event in the last 5 years) * diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio \>2,5)

Keywords: diabetes protein protein hydrolysate
reduction of ldl-c with pcsk9 inhibition in heterozygous familial hypercholesterolemia disorder study-2

Conditions: Hyperlipidemia

Summary: the primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (q2w) and once monthly (qm), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (ldl-c) in adults with heterozygous familial hypercholesterolemia (hefh).


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 to ≤ 80 years of age * diagnosis of heterozygous familial hypercholesterolemia * on a stable dose of an approved statin and lipid regulating medication * fasting ldl-c ≥ 100 mg/dl (2.6 mmol/l) * fasting triglycerides ≤ 400 mg/dl (4.5 mmol/l) exclusion criteria: * homozygous familial hypercholesterolemia * ldl or plasma apheresis * new york heart association (nyha) iii or iv heart failure * uncontrolled cardiac arrhythmia * uncontrolled hypertension * type 1 diabetes, poorly controlled type 2 diabetes * uncontrolled hypothyroidism or hyperthyroidism

Keywords: high cholesterol, treatment for high cholesterol, lowering cholesterol, lowering high cholesterol, hypercholesterolemia
closed-loop double-vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section

Conditions: Hypotension

Summary: hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. the investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (cnap, cnsystems, austria).

hypotension occurs commonly during spinal anesthesia for cesarean section with maternal and fetal adverse effects. the investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure (cnap, cnsystems, austria) monitoring feeding hemodynamic data to a laptop computer, which triggers syringe pumps to deliver phenylephrine 50mcg or ephedrine 4mg (if heart rate\<60 beats.min-1) every 30 seconds when systolic blood pressure fell to below 90% of baseline. a randomised controlled trial was done to compare with manual bolus technique. with the manual bolus technique, phenylephrine 100mcg or ephedrine 8mg (if heart rate\<60 beats.min-1) was given every 60 seconds by the attending anesthesiologist when systolic blood pressure was below 90% of baseline as measured by conventional intermittent non-invasive blood pressure monitoring.

Eligibility criteria:
inclusion criteria: * age 21-45 years old, * weight 40-90 kg, * height 145-170 cm exclusion criteria: * contraindications to spinal anaesthesia, * allergy to drugs used in the study, and * those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease

Keywords: hypotension spinal anesthesia cesarean section phenylephrine ephedrine closed-loop system continuous non-invasive monitor
a study of mk2206 in locally advanced or metastatic solid tumors (2206-007)

Conditions: Solid Tumors

Summary: this study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of mk2206 when administered with every other day (qod) and once weekly (qw) dosing schedules.


Eligibility criteria:
inclusion criteria: * patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy * has adequate organ function * is ecog performance scale 0-1 * has a negative urine pregnancy test if patient is female * is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis exclusion criteria: * patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment * is currently participating or has participated in a study with an investigational compound or device within 28 days * has a primary central nervous system tumor * has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure * is a known diabetic who is taking insulin or oral antidiabetic therapy * is pregnant or breastfeeding or planning to become pregnant during the study * is positive hiv antibody, hbs antigen or hcv antibody

Keywords: locally advanced or metastatic solid tumors